Gilead’s Remdesivir Gets Emergency FDA Authorization
In a big development with the experimental drug we have been covering recently, Remdesivir has received approval for emergency use for Coronavirus. The President of the United States announced this approval in the Oval Office alongside Gilead’s CEO Daniel O’Day. This approval is based on previous testing showing that Remdesivir has helped patients with moderate to severe symptoms of the virus recover more quickly than standard care.
The Emergency Use Authorization means that the drug has not gone through the same amount of review as an FDA-approved treatment. Under the authorization, doctors will be allowed to use the drug on patients hospitalized with Covid-19 even though the drug has not been formally approved by the FDA.
The FDA authorized a similar EUA for chloroquine and hydroxychloroquine to treat the virus, however later on they issued a warning against taking the drugs outside of a hospital or within a clinical trial after reports of “serious heart rhythm problems” in patients.
The previous testing done involved a trial of nearly 400 patients with severe cases of coronavirus, showing at least half of the patients treated with a five-day dosage of Remdesivir had improved conditions. Under the EUA, the drug will be allowed to be administered as a five- or ten-day dose.
It is important to keep in mind that this is not the same as the drug being approved. US health officials still caution that new data on the drug has yet to be peer reviewed.
Nevertheless, Gilead expects to produce more than 140,000 rounds of their 10-day dose by the end of the month, and may be able to make 1 million by the end of the year.
As always, we remind our readers to check back often for up to date news and posts about experimental drug treatments regarding Covid-19